Data / Medical devices / China / Xingaoyi Medical Equipment Co., Ltd
Xingaoyi Medical Equipment Co., Ltd: FDA-registered device maker in Yuyao Zhejiang, China, 2 510(k) clearances
Xingaoyi Medical Equipment Co., Ltd is registered with the FDA (registration 3008156140) in Yuyao Zhejiang, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008156140
- Address
- 555 Yeshan Road, Yuyao Zhejiang, China, 315400
- Owner or operator
- Xingaoyi Medical Equipment Co.,Ltd (10030929)
- Roles
- Manufacturer
- First device listed
- December 1, 2009
- Registered through
- 2027
- Brand names listed
- GreenMR Serenity 1.5T, MagicScan-1.5, XGY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 17, 2026 | K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | LNH | Substantially Equivalent | Xingaoyi Medical Equipment Co.,Ltd | accessdata.fda.gov |
| November 10, 2009 | K092899 | OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 | LNH | Substantially Equivalent | Ningbo Xingaoyi Magnetism Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.